EC Issues GMP Guidelines for Certain Advanced Therapies

The European Commission has issued a set of guidelines on good manufacturing practices (GMP) specific to advanced therapy medicinal products (ATMPs).

ATMPs are medicines for human use that are based on genes or cells. Particularly, they are used for severe, untreatable, or chronic diseases for which conventional approaches have proven to be inadequate, according to information from the European Medicines Agency (EMA).

The new guidelines adapt the European Union GMP requirements to the specific characteristics of ATMPs and address the manufacturing scenarios used for these products, according to the EMA.

“The guidelines foster a risk-based approach to manufacture and testing of such products,” said the EMA in a statement. “The guidelines are meant to ensure that these medicinal products are consistently produced and controlled according to high-quality standards, for the benefit and the safety of patients.” This initiative is part of the joint action plan launched by the European Commission’s Directorate General for Health and Food Safety and the EMA in October 2017 to foster the development of ATMPs.

The European Commission drafted these guidelines with input from the agency’s Committee for Advanced Therapies and GMP/Good Distribution Practice inspectors working group, together with national competent authorities and other external stakeholders, according to the EMA.

Source: European Medicines Agency


Leave a Reply

Your email address will not be published. Required fields are marked *